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Cost-utility analysis of pharmacogenomics-guided tacrolimus treatment of Slovenian patients undergoing kidney transplantation in the U-PGx PREPARE study

The Pharmacogenomics Journal volume 25, Article number: 6 (2025) Cite this article

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Abstract

Tacrolimus (TAC) is one of the most widely prescribed maintenance immunosuppressant drugs in solid organ transplantation. Kidney transplantation is often the preferred treatment for patients with the kidney failure and is complemented with TAC treatment. TAC treatment is often associated with adverse drug events, which can be reduced by pharmacogenomic (PGx)-guided prescription. We conducted a cost-utility analysis to assess the cost-effectiveness of PGx-guided TAC treatment versus the conventional scheme in patients who recently underwent kidney transplantation in Slovenia. Clinical data were collected from the PREPARE study. The effectiveness of the treatment was determined by mean survival and utility values and Incremental Cost-Effectiveness Ratio was also calculated. Costs of PGx-guided treatment was comparable to conventional treatment but shared reduced risk for severe ADEs and 43% improved quality of life. PGx-guided arm showed a mean of 0.956 Quality-Adjusted Life Years (QALYs) (95% CI: 0.900–1.014) compared to 0.862 QALYs (95%CI: 0.801–0.918) in the other arm. Probabilistic sensitivity analyses confirmed the results’ robustness. In conclusion, PGx-guided treatment represents a cost-effective option for the TAC treatment of kidney-transplanted patients in the Slovenian healthcare setting.

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Fig. 1: Evolution of Utility Values as an Index between patients getting PGx-guided treatment and patients under conventional therapy.
Fig. 2: Scatter Plot of Probabilistic Analysis.
Fig. 3: Cost-effectiveness acceptability curve of PGx-guided arm vs control arm.

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Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author upon request.

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Acknowledgements

This study has received funding from a European Commission grant (H2020-668353; U-PGx) to GPP, VD and CM.

Funding

The project was funded by the European Commission Horizon 2020 Program via Grant Agreement 668353 (U-PGx; www.upgx.eu).

Author information

Authors and Affiliations

  1. The Golden Helix Foundation, London, UK

    Vasileios Fragoulakis & Christina Mitropoulou

  2. University of Patras, School of Health Sciences, Department of Pharmacy, Laboratory of Pharmacogenomics and Individualized Therapy, Patras, Greece

    Margarita-Ioanna Koufaki & George P. Patrinos

  3. University Medical Centre Ljubljana, Ljubljana, Slovenia

    Gregor Mlinšek & Jasna Klen

  4. University of Ljubljana, Faculty of Medicine, Ljubljana, Slovenia

    Gregor Mlinšek & Jasna Klen

  5. University of Ljubljana, Faculty of Medicine, Institute of Biochemistry and Molecular Genetics, Pharmacogenetics Laboratory, Ljubljana, Slovenia

    Tanja Blagus & Vita Dolžan

  6. United Arab Emirates University, College of Medicine and Health Sciences, Department of Genetics and Genomics, Al-Ain, Abu Dhabi, United Arab Emirates

    George P. Patrinos & Christina Mitropoulou

  7. United Arab Emirates University, Zayed Center for Health Sciences, Al-Ain, Abu Dhabi, United Arab Emirates

    George P. Patrinos

Authors
  1. Vasileios Fragoulakis
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  2. Margarita-Ioanna Koufaki
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  3. Gregor Mlinšek
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  7. Vita Dolžan
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  8. Christina Mitropoulou
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Contributions

All authors contributed to the conception, design, and drafting of the paper. Data collection and documentation in eCRF were performed by the Slovenian clinical team (GM and JK) and researchers (TB and VD) working on the PREPARE study. CM, VD and GPP was one of the delegated persons, responsible for the design and the conduction of PREPARE project. VF and MIK reviewed and curated the study’s database. VF and MIK conducted data analysis. VF and MIK drafted the first version of the manuscript. CM and GPP drafted all subsequent versions of the manuscript. All authors reviewed the final version of the original and revised manuscript. VF and MIK are the guarantors for the overall content.

Corresponding author

Correspondence to Christina Mitropoulou.

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Ethics approval

The study was approved by the National Medical Ethics Committee of the Republic of Slovenia (0120-591/2016; KME 44/12/16).

Competing interests

The authors declare no competing interests.

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Fragoulakis, V., Koufaki, MI., Mlinšek, G. et al. Cost-utility analysis of pharmacogenomics-guided tacrolimus treatment of Slovenian patients undergoing kidney transplantation in the U-PGx PREPARE study. Pharmacogenomics J 25, 6 (2025). https://doi.org/10.1038/s41397-025-00365-2

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